NCT07366190

PIOMI Effects on Preterm Infant Outcomes

Effects of Premature Infant Oral Motor Intervention (PIOMI) on Feeding Behavior, Weight Gain, and Length of Hospital Stay in Preterm Infants: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Necmettin Erbakan University · Academic / Other
• Sex: All
• Age: 24 Weeks – 30 Weeks
• Healthy volunteers: Accepted

Summary

Objective: This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on body weight gain, breastfeeding behavior, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU). Methods: A randomized controlled experimental study design was used. A total of 32 preterm infants with gestational age between 26-30 weeks were randomly assigned to the intervention group (n=16) or control group (n=16). The intervention group received PIOMI twice daily for 7 consecutive days (14 sessions in total), while the control group received routine care only. The Premature Infant Breastfeeding Behavior Scale (PIBBS) was used to evaluate breastfeeding performance before and after the intervention. Weight changes and length of hospital stay were recorded and compared between groups.

Detailed description

Objective This study aimed to investigate the effects of Premature Infant Oral Motor Intervention (PIOMI) on feeding behavior, weight gain, and length of hospital stay in preterm infants hospitalized in the neonatal intensive care unit (NICU). Methods This study was designed as a randomized controlled experimental trial with a pretest-posttest parallel-group design. A total of 32 preterm infants with a gestational age between 26 and 30 weeks were randomly assigned to either the intervention group (n = 16) or the control group (n = 16). The intervention group received Premature Infant Oral Motor Intervention (PIOMI) twice daily for 7 consecutive days (14 sessions in total), while the control group received routine nursing care only. Breastfeeding behavior was assessed using the Premature Infant Breastfeeding Behavior Scale (PIBBS) before and after the intervention. Body weight was measured daily, and total weight gain and length of hospital stay were recorded. Statistical analyses were performed using appropriate parametric and non-parametric tests according to data distribution, with a significance level set at p \< 0.05. Conclusion This study was designed to evaluate the clinical effects of PIOMI on feeding performance, weight gain, and hospitalization outcomes in preterm infants.

Conditions

• Prematurity

Interventions

Type	Name	Description
OTHER	Premature Infant Oral Motor Intervention (PIOMI)	The Beckman Oral Motor Intervention (BOMI) was redesigned by Dr. Brenda Lessen, modifying its duration and steps, to create the Premature Infant Oral Motor Intervention (PIOMI). PIOMI is the only preterm oral motor intervention that can be consistently and reliably applied and easily taught through a specific training program.In the intervention group, physiotherapists administered PIOMI, which consisted of cheek support, lip rounding, lip closure, gum massage, pressure on the lateral and anterior tip of the tongue, and palate tapping to stimulate sucking. The intervention lasted 3 minutes, followed by 2 minutes of non-nutritive sucking, administered twice daily for 7 consecutive days (each session lasting 5 minutes). Oxygen saturation and heart rate were monitored during the application.
OTHER	nursing care	The control group received routine nursing care without any additional oral motor stimulation.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Turkey (Türkiye)